| Combination of | |
|---|---|
| Taurolidine | Thiadiazinane antimicrobial |
| Heparin | Anti-coagulant |
| Clinical data | |
| Trade names | Defencath |
| AHFS/Drugs.com | Defencath |
| License data | |
| Routes of administration | Intraluminal |
| ATC code |
|
| Legal status | |
| Legal status | |
| Identifiers | |
| KEGG | |
Taurolidine/heparin, sold under the brand name Defencath, is a fixed-dose combination catheter lock solution used for central venous catheter instillation.[1][2] It contains taurolidine, a thiadiazinane antimicrobial; and heparin, an anti-coagulant. Its use is limited to people with kidney failure receiving chronic hemodialysis through a central venous catheter.[1][2]
The most frequently reported adverse reactions include hemodialysis catheter malfunction, hemorrhage/bleeding, nausea, vomiting, dizziness, musculoskeletal chest pain, and thrombocytopenia.[2]
Taurolidine/heparin was approved for medical use in the United States in November 2023.[2][3] The US Food and Drug Administration (FDA) considers it to be a first-in-class medication.[4]
Medical uses
Taurolidine/heparin is indicated to reduce catheter-related bloodstream infections in adults with kidney failure who are receiving chronic hemodialysis through a central venous catheter.[1][2][5] It is indicated in this limited and specific patient population.[1][2]
History
Taurolidine/heparin was studied in a single, randomized, active-controlled phase III clinical trial.[2] In this trial, taurolidine/heparin delayed the time it took to acquire a catheter related bloodstream infection.[2] Taurolidine/heparin demonstrated a 71% risk reduction in catheter related bloodstream infections versus the heparin comparator arm (95% confidence interval for risk reduction: 38% to 86%; p value = 0.0006).[2]
References
- 1 2 3 4 5 "Defencath- taurolidine and heparin solution". DailyMed. 29 November 2023. Archived from the original on 12 December 2023. Retrieved 12 December 2023.
- 1 2 3 4 5 6 7 8 9 "FDA approves new drug under special pathway for patients receiving hemodialysis". U.S. Food and Drug Administration (FDA). 15 November 2023. Archived from the original on 12 December 2023. Retrieved 16 November 2023.
This article incorporates text from this source, which is in the public domain. - ↑ "CorMedix Inc. Announces FDA Approval of Defencath to Reduce the Incidence of Catheter-Related Bloodstream Infections in Adult Hemodialysis Patients" (Press release). Cormedix Inc. 15 November 2023. Archived from the original on 12 December 2023. Retrieved 16 November 2023 – via GlobeNewswire.
- ↑ New Drug Therapy Approvals 2023 (PDF). U.S. Food and Drug Administration (FDA) (Report). January 2024. Archived from the original on 10 January 2024. Retrieved 9 January 2024.
- ↑ Guo Q, Lv Z, Wang H, Song L, Liu Y, Chen H, et al. (December 2021). "Catheter lock solutions for reducing catheter-related bloodstream infections in paediatric patients: a network meta-analysis". The Journal of Hospital Infection. 118: 40–47. doi:10.1016/j.jhin.2021.09.013. PMID 34560168. S2CID 237626477.